Skip to content
DataLookout
Start free
Menu

REGALSNCT05695521

Regulatory T Cells for Amyotrophic Lateral Sclerosis

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Cellenkos, Inc.

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 11 versions: 8 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 2026 to May 2027
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Publications: details revised at 43 of 47 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v10
  3. Study sites: 2 to 3v9
  4. Site contacts updated at 1 of 2 sitesv8
  5. Site contacts updated at 1 of 2 sitesv7
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 2v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 2025 to May 2026
    • Start date changed from estimate of Jan 30, 2023 to Apr 3, 2023
    • Site details revised
    v4
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Treatment Limiting Toxicity (TLT)
Timeframe: 28 days
Combined assessment of function and survival (CAFS)
Timeframe: 24 weeks

Secondary (9)

Incidence of all cause AEs and SAEs
ALS Functional Rating Scale-Revised (ALSFRS-R) Score
Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R)
Slow Vital Capacity (SVC)
Handheld dynamometer (HHD)
Show 4 moreShow less
Nfl CSF
Nfl Serum
Ventilation assistance-free survival (VAFS)
Overall Survival (OS)

Arms and interventions

CK0803Experimental

CK0803 (cryopreserved, allogeneic, cord blood derived T regulatory cells that express neurotropic homing markers) will be administered intravenously Dose: 100 million Treg cells (fixed dose) Dose regimen: * Induction: one infusion every 7 days (+/-3) x 4 doses * Consolidation: one infusion every 28 days (+/-3) x 5 doses

PlaceboPlacebo comparator

Excipient

Biologicals: CK0803

Other: Excipient

Sites

3 sites in 1 country